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4.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 627-632, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31810392

RESUMO

Introduction: There is significant difference in utilization of patented medicines in the EU, as pharmaceuticals at Western European price levels are usually not cost-effective in Central and Eastern European (CEE) countries. The article reviews options to solve the 'financing gap' posed by the challenge of covering patented medicines from more restricted resources in countries with greater unmet medical need.Areas covered: Hidden volume restrictions to patented pharmaceuticals implemented by payers to facilitate financial sustainability may increase European inequity in patient access. Confidential price discounts and financial risk-sharing agreements improve cost-effectiveness of pharmaceuticals with limited impact on the European floor price. Narrowing the eligible group of patients on the positive drug list can help to target the medicines to patients with potentially greater health benefit whilst reducing the budget impact. Pay-for-performance schemes can improve cost-effectiveness of pharmaceuticals with significant uncertainty or heterogeneity in the magnitude of added therapeutic value. Increased utilization of off-patent pharmaceuticals can increase patient access through re-investing the savings from generic or biosimilar price erosion.Expert opinion: Transparent and sustainable pharmaceutical policies aiming to improve the allocative efficiency of scarce resources should be implemented in CEE to reduce financing gap and improve patient access to high-cost medicines.


Assuntos
Custos de Medicamentos/estatística & dados numéricos , Acesso aos Serviços de Saúde/economia , Preparações Farmacêuticas/provisão & distribução , Reembolso de Incentivo/economia , Análise Custo-Benefício , Controle de Medicamentos e Entorpecentes , Farmacoeconomia , União Europeia , Humanos , Patentes como Assunto , Preparações Farmacêuticas/economia , Participação no Risco Financeiro/economia
5.
Global Health ; 15(Suppl 1): 78, 2019 11 28.
Artigo em Inglês | MEDLINE | ID: mdl-31775767

RESUMO

BACKGROUND: Trade and investment agreements negotiated after the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the large body of literature on intellectual property and access to affordable medicines, the ways in which other provisions in trade agreements can affect pharmaceutical policy and, in turn, access to medicines have been little studied. There is a need for an analytical framework covering the full range of provisions, pathways, and potential impacts, on which to base future health and human rights impact assessment and research. A framework exploring the ways in which trade and investment agreements may affect pharmaceutical policy was developed, based on an analysis of four recently negotiated regional trade agreements. First a set of core pharmaceutical policy objectives based on international consensus was identified. A systematic comparative analysis of the publicly available legal texts of the four agreements was undertaken, and the potential impacts of the provisions in these agreements on the core pharmaceutical policy objectives were traced through an analysis of possible pathways. RESULTS: An analytical framework is presented, linking ten types of provisions in the four trade agreements to potential impacts on four core pharmaceutical policy objectives (access and affordability; safety, efficacy, and quality; rational use of medicines; and local production capacity and health security) via various pathways. CONCLUSIONS: The analytical framework highlights provisions in trade and investment agreements that need to be examined, pathways that should be explored, and potential impacts that should be taken into consideration with respect to pharmaceutical policy. This may serve as a useful checklist or template for health and human rights impact assessments and research on the implications of trade agreements for pharmaceuticals.


Assuntos
Comércio/legislação & jurisprudência , Cooperação Internacional/legislação & jurisprudência , Investimentos em Saúde/legislação & jurisprudência , Preparações Farmacêuticas/economia , Política Pública , Canadá , Custos e Análise de Custo , Acesso aos Serviços de Saúde , Humanos , Propriedade Intelectual , México , Estados Unidos
7.
Expert Opin Ther Pat ; 29(8): 653-662, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31298053

RESUMO

Introduction: The Ecuadorian Institute of Intellectual Property (IEPI) granted several compulsory licenses between 2011 and 2017. In 2009, the President of Ecuador signed a decree that was intended to facilitate the request of compulsory licenses (CL) in the country, not only for Enfarma EP but for any privately owned local company in order to produce more accessible medicines. Areas covered: The national and international regulatory framework of pharmaceutical patents and the local applicability of CL in Ecuador. The authors also analyzed the results of requesting unplanned and epidemiologically unnecessary CL at a national level. Finally, the authors reviewed the effects of requesting, granting or denying CL on price per unit in the last 7 years of available data. Expert opinion: The authors think that compulsory licenses are useful tools when negotiating drug prices or when the demand cannot be satisfied due to economic constrain within the local health system. However, the authors' experience suggests that Ecuador did not have an established and reliable production system neither an adequate plan before requesting CL, therefore the positive effects of this measure were not clearly established.


Assuntos
Custos de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Licenciamento/economia , Indústria Farmacêutica/economia , Equador , Acesso aos Serviços de Saúde , Humanos , Propriedade Intelectual , Patentes como Assunto/legislação & jurisprudência , Preparações Farmacêuticas/economia , Preparações Farmacêuticas/provisão & distribução
8.
S Afr Med J ; 109(6): 387-391, 2019 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-31266556

RESUMO

South Africa (SA) is in the process of amending its patent laws. Since its 2011 inception, Fix the Patent Laws, a coalition of 40 patient groups, has advocated for reform of SA's patent laws to improve affordability of medicines in the country. Building on two draft policies (2013, 2017) and a consultative framework (2016) for reform of SA's patent laws, Cabinet approved phase 1 of the Intellectual Property Policy of the Republic of South Africa on 23 May 2018. Fix the Patent Laws welcomed the policy, but highlighted concerns regarding the absence of important technical details, as well as the urgent need for government to develop bills, regulations and guidelines to provide technical detail and to codify and implement patent law reform in the country. In this article, we explore how reforms proposed in SA's new intellectual property policy could improve access to medicine through four medicine case studies.


Assuntos
Custos de Medicamentos , Acesso aos Serviços de Saúde , Patentes como Assunto/legislação & jurisprudência , Preparações Farmacêuticas/economia , Antineoplásicos/economia , Antivirais/economia , Custos e Análise de Custo , Indústria Farmacêutica , Cloridrato de Erlotinib/economia , Guanina/análogos & derivados , Guanina/economia , Humanos , Fatores Imunológicos/economia , Lenalidomida/economia , Sorafenibe/economia , África do Sul
9.
Public Health ; 173: 1-4, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31203136

RESUMO

OBJECTIVE: The short communication is prompted by the debate relating to the effect of pharmaceutical patents on access to affordable medicines, particularly in Africa. A recent amendment made to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement creates a policy space for the regional alliance of low-income countries for the collective procurement and local production of drugs under compulsory licensing. This article examines the extent to which the regional mechanism can deliver access to pharmaceuticals. The article examines the regional mechanism in the light of the recent regional trade agreements and pharmaceutical plans of some regional economic blocs in Africa as well as the newly signed African Continental Free Trade Agreement (AfCFTA). STUDY DESIGN: This short communication adopts a descriptive approach in linking the regional mechanism in the TRIPS amendment to the regional trade agreements of African countries at the subregional and continental levels. METHODS: To ascertain the extent to which TRIPS Agreements regional model can deliver access to medicines in Africa, the article adopts a desk review approach by examining the relevant provisions of TRIPS Agreement, particularly the newly added Article 31bis, and the provisions of the relevant regional and continental free trade agreements in Africa. RESULTS: The article finds that although the regional model has great prospects in supporting the wider effort to deliver access to medicine, the limitations to its operative utilization may weaken its potency in addressing the urgent public health needs of the continent. CONCLUSION: The article concludes by stressing the inevitability of Africa's integration in tackling the deficiency of access to generic medicines in Africa. It was noted that even though there could be some potential challenges, the regional mechanism is indeed the way to go for low-income countries.


Assuntos
Acesso aos Serviços de Saúde , Propriedade Intelectual , Cooperação Internacional , Preparações Farmacêuticas/provisão & distribução , Saúde Pública , África , Comércio/economia , Comércio/legislação & jurisprudência , Indústria Farmacêutica/economia , Indústria Farmacêutica/legislação & jurisprudência , Acesso aos Serviços de Saúde/economia , Acesso aos Serviços de Saúde/legislação & jurisprudência , Humanos , Cooperação Internacional/legislação & jurisprudência , Patentes como Assunto/legislação & jurisprudência , Preparações Farmacêuticas/economia , Políticas , Pobreza
10.
Manag Care ; 28(6): 30-33, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31188097

RESUMO

Insurers and some drug manufacturers are turning to the Institute for Clinical and Economic Review (ICER) as the arbiter of drug prices, especially as prices soar and value is sought. But questions persist about the cost-effectiveness calculations of the Boston not-for-profit and its dependence on QALYs.


Assuntos
Análise Custo-Benefício , Preparações Farmacêuticas/economia , Boston , Custos e Análise de Custo , Indústria Farmacêutica , Anos de Vida Ajustados por Qualidade de Vida
13.
Aging Clin Exp Res ; 31(6): 875-880, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30847844

RESUMO

BACKGROUND: The financial impact associated with drug consumption has been poorly investigated among frail subjects and, specifically, in nursing home settings. AIMS: To determine the association of the average monthly cost of the drugs and dietary supplements consumed by nursing home residents with their frailty status. METHODS: This is an analysis of the first follow-up year of the SENIOR cohort. All participants were classified into "frail" or "non-frail" categories according to Fried's criteria at baseline. Monthly bills from the pharmacy were analysed to determine the association between the average monthly cost of the drugs and dietary supplements consumed and frailty status. RESULTS: A sample of 87 residents (83.8 ± 9.33 years and 75.9% women) from the SENIOR cohort was included. The prevalence of frailty was 28%. The median number of medications consumed each day was 9 (6-12) (no difference between frail and non-frail subjects; p = 0.15). The overall median monthly cost was € 109.6, of which 49% was covered by Belgian social security and the remaining balance was paid by the patient. When comparing the drug expenses of the frail subjects and the non-frail subjects, the overall average monthly cost did not differ between the 2 groups (p = 0.057). Nevertheless, the expenditure remaining to be paid by the residents, after the Belgian social security intervention, was significantly higher among the frail residents (€ 65.7) than among the non-frail residents (€ 47.6; p = 0.017). CONCLUSIONS: Frailty status has an impact on the expenditures related to the consumption of drugs.


Assuntos
Suplementos Nutricionais/economia , Fragilidade/economia , Casas de Saúde/estatística & dados numéricos , Preparações Farmacêuticas/economia , Idoso , Idoso de 80 Anos ou mais , Bélgica , Estudos de Coortes , Feminino , Seguimentos , Idoso Fragilizado/estatística & dados numéricos , Fragilidade/epidemiologia , Humanos , Masculino , Prevalência , Previdência Social/economia
14.
Cad Saude Publica ; 35(3): e00153118, 2019 03 25.
Artigo em Inglês, Português | MEDLINE | ID: mdl-30916181

RESUMO

The enormous development of genomics research in recent decades has raised great expectations concerning its impact on biomedicine. There has been growing investment in research in personalized or precision medicine, which aims to customize medical practice with a focus on the individual, based on the use of genetic tests, identification of biomarkers, and development of targeted drugs. However, the personalized or precision medicine movement is controversial and has sparked an important debate between its defenders and critics. This essay aims to discuss the assumptions, promises, limits, and possibilities of personalized or precision medicine based on a review of the recent literature situating the debate on the theme. The review indicates that many of the promises of personalized or precision medicine remain unfulfilled. While there has been huge progress in knowledge on the molecular mechanisms of diseases and the development of drugs that have significantly impacted the treatment of some types of cancer, thus far there is no evidence that this same pattern will be reproduced in other complex diseases. Personalized or precision medicine is expected to generate incremental developments in specific areas of medicine, but there are obstacles to its generalization. The high cost of new biotechnologies can exacerbate health inequalities and become a problem for health services' sustainability, especially in low and middle-income countries. The emphasis on personalized or precision medicine may shift funds away from less costly interventions that have greater public health impact.


Assuntos
Tecnologia Biomédica/tendências , Medicina de Precisão/tendências , Tecnologia Biomédica/economia , Genômica/economia , Genômica/métodos , Equidade em Saúde , Humanos , Neoplasias/economia , Neoplasias/terapia , Preparações Farmacêuticas/economia , Medicina de Precisão/economia
15.
Int Health ; 11(5): 379-402, 2019 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-30916303

RESUMO

Medicine and medical device donations have the potential to improve access to healthcare in some of the poorest parts of the world, but can do more harm than good. World Health Organization guidelines advise donors on how to make effective and useful donations. Our objective was to assess compliance of recent medicine or medical device donations with WHO guidelines from 2009 onwards. We searched media, academic and gray literature, including industry and organizational documents, to identify reports describing specific incidences of the donation of medicines or devices. We collected data on donation characteristics and guideline compliance. We identified 88 reports describing 53 donations. Most did not comply with at least some items in WHO guidelines and no reports provided sufficient information to assess compliance against all items. Donations that fail to comply with guidelines may be excessive, expired and/or burden recipient countries with storage and disposal costs. It was estimated that 40-70% of donated medical devices are not used as they are not functional, appropriate, or staff lack training. More effective donations involved needs assessments, training and the use of existing distribution networks. The donation of medicines and medical devices is frequently inadequately reported and at times inappropriate. Guidelines need to be enforced to ensure effective donations.


Assuntos
Equipamentos e Provisões , Doações , Fidelidade a Diretrizes/estatística & dados numéricos , Preparações Farmacêuticas , Equipamentos e Provisões/economia , Guias como Assunto , Humanos , Preparações Farmacêuticas/economia , Organização Mundial da Saúde
16.
Eur J Clin Pharmacol ; 75(7): 895-900, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30877328

RESUMO

PURPOSE: Centrally authorised medicinal products (CAMPs) in the European Union may offer added therapeutic value (ATV) but may be linked to high prices and limited efficiency. Health technology assessment (HTA) and managed entry schemes (MES) may facilitate the reimbursement decision by providing reliable estimates of the medicinal product's value and costs and by controlling the remaining uncertainty, respectively. We investigated the impact of HTA criteria and the initiation of a MES on the reimbursement decision of CAMPs in Belgium. METHODS: We selected all reimbursement submissions for new centrally authorised medicinal products in the 2010-2015 period. We retrieved data relating to the reimbursement decision, the HTA outcome and the use of a managed entry scheme. RESULTS: The decision of the Minister was available for 115 dossiers, covering 36 (31.3%) orphan medicinal products (OMPs) and 79 ATV products. A MES was used in 41 submissions. A positive reimbursement decision was obtained in 65% of cases. The significant factors affecting the reimbursement decision were the approval of ATV, the medical need if it was considered 'important or major' and the use of a managed entry scheme. Price, budget impact and efficiency had no significant impact. CONCLUSIONS: Added therapeutic value and high medical need increase the odds for a positive reimbursement decision. No impact could be demonstrated of the cost-related HTA criteria. Cost elements may be biased by the use of a confidential MES. Without a MES, only 53% of the centrally authorised medicinal products, including OMPs, are reimbursed in Belgium.


Assuntos
Preparações Farmacêuticas/economia , Mecanismo de Reembolso , Avaliação da Tecnologia Biomédica , Bélgica , Tomada de Decisões
17.
Daru ; 27(1): 169-177, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30903556

RESUMO

BACKGROUND: In the past decades, economic sanctions imposed on Iran for its nuclear program. The embargo made difficulty in foreign trade and led to lack of timely access to medicines. As the internationally-led sanctions caused to the shortage of medicine there, healthcare systems need to applied the new policies for maintaining health service quality especially in pharmaceutical sector. OBJECTIVES: This paper is about policies applied in Iran health system during the crisis reached its peak in 2012 as a good experience for guarantying access to pharmaceutical products. METHODS: Through interviewing experts and managers in pharmaceutical regulatory system, the implemented policies in targeted historical period were extracted, then quantitative data were analyzed to show the impact of the policies on the access and affordability of medicines before and after their implementation in Iran food and drug administration (IFDA). This paper tries to show strategies employed by to tackle the crisis caused by sanctions and to offer practical policies to make medicines more accessible at the time of crisis. RESULTS: In order to reduce the harmful effects of this crisis, IFDA proposed some changes at different levels ranging from organizational procedures to parliament legislations. The main achievements of IFDA were making drugs easily available are as follows, significantly reducing prices, decreasing the share of market regarding the imported medicines, facilitating the manufacture of domestic medicines, encouraging foreign investment in manufacturing drugs domestically, controlling the shortage of drugs, and finally giving financial support to all patients in general and to those patients who had problem paying for drugs in particular. CONCLUSION: These experiences which made the Iran pharmaceutical sector survive during the international sanctions, can be considered as a good example of resilience strategies in similar situations. Graphical abstract IFDA policies to improve access to pharmaceutical products in sanction.


Assuntos
Indústria Farmacêutica/legislação & jurisprudência , Legislação de Medicamentos/organização & administração , Preparações Farmacêuticas/provisão & distribução , Acesso aos Serviços de Saúde/legislação & jurisprudência , Humanos , Irã (Geográfico) , Preparações Farmacêuticas/economia , Política
18.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 743-748, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30821532

RESUMO

Background: Traditional drug payment schemes in Catalonia are generally based on the negotiation of fixed prices; however, disadvantages arise in the case of innovative therapies. Risk sharing agreements distribute potential health and economic uncertainties and high prices on access across the interested parts.Objectives: To identify, characterize and analyze current publicly available agreement reports signed by the Catalan Health Service and different pharmaceutical companies evaluating the current market access scene for new drugs in Catalonia.Methods: A database of agreements implemented between 2013 and 2018 was developed by using publicly available data. Data analysis was performed in a descriptive way, presenting summaries in datasheets.Results: A total of 7 managed entry agreements were analyzed. Two extensions regarding previous agreements were also taken into account. The main involved disease area is oncology (57%) and the most common length is 1 year, whereas the longest is 3 years.Conclusions: Managed entry agreements are gaining popularity and are viewed as positive schemes by stakeholders, payers and health services, leading to a general increase of accords during the last years. However, there are hardly any studies regarding the impact of RSA post-implementation, a field of great relevance regarding health policies.


Assuntos
Custos de Medicamentos , Indústria Farmacêutica/economia , Participação no Risco Financeiro/economia , Farmacoeconomia , Política de Saúde , Acesso aos Serviços de Saúde/economia , Humanos , Preparações Farmacêuticas/economia , Participação no Risco Financeiro/organização & administração , Espanha , Fatores de Tempo
20.
J Evid Based Med ; 12(1): 9-15, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30701688

RESUMO

BACKGROUND: Since January 2011, the Federal Joint Committee (FJC) conducts early benefit assessments (EBA) of newly approved pharmaceutical drugs compared to appropriate standard therapies. The FJC commissions the Institute for Quality and Efficiency in Healthcare (IQEH) to prepare preliminary reports. We aimed to evaluate the extent, impact, and reason for different judgments on added benefit of both institutions. METHODS: We searched EBA data on the FJC website and included completed procedures from 2011 to 2017. We conducted a quantitative analysis of the difference between FJC and IQEH on divergent judgments, a quantitative analysis of the impact of EBA on market withdrawal, and a qualitative analysis to identify potential factors contributing to divergent judgments. RESULTS: FJC rated an added benefit in 30% (139 of 457) and IQEH in 22% (101 of 457) matching research questions (P = 0.004). In the aftermath of EBA, 28 pharmaceutical drugs were withdrawn from the German market. We identified three potential factors that might have contributed to the divergent judgments. IQEH used a unique threshold concept to define the rating, FJC conducted additional public hearings, and FJC showed more flexibility with adherence to stringent criteria and interpretation of results. CONCLUSIONS: FJC and IQEH differed significantly in their early benefit assessment. In response to negative EBA decisions, pharmaceutical companies withdrew a considerable number of medicines from the German market. The present work uncovers the subjectivity and possible variance inherent in benefit assessment, as the two institutions observe the same rules of procedure.


Assuntos
Comitês Consultivos , Custos de Medicamentos , Preparações Farmacêuticas/economia , Vigilância de Produtos Comercializados/métodos , Análise Custo-Benefício/métodos , Aprovação de Drogas , Governo Federal , Alemanha , Humanos , Fatores de Tempo
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